Overview
- 11 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-10-10.
At a glance
Inspections
11
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 10 Oct 2025 | Medical Devices & Rad Health | Clean | |
| 5 Jan 2023 – 26 Jan 2023 | Medical Devices & Rad Health | Clean | |
| 4 Jan 2022 – 7 Jan 2022 | Medical Devices & Rad Health | Clean | |
| 13 Nov 2017 – 15 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 11 Apr 2016 – 13 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 24 Feb 2015 – 26 Feb 2015 | Medical Devices & Rad Health | Clean | |
| 12 Jan 2015 – 14 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2011 | Not recorded | Clean | |
| 2 Jun 2011 | Not recorded | Clean | |
| 1 Aug 2008 | Not recorded | 483 | On file |
| 7 Jun 2001 | Not recorded | Clean |
Investigators
FDA investigators tied to this site in the record.
Charles L Larson6 insp.
Courtney R Bratina1 insp.
Audrey J Yarbrough1 insp.
Marlo-Ian M Alintanahin1 insp.
Julian C Hanson1 insp.
Kaitlyn T Dang1 insp.
Michael D Garcia1 insp.
Lucas B Leake1 insp.
William S Vitale1 insp.
Full site report
Get the verbatim findings behind W L Gore & Associates, Inc.'s 1 Form 483
The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat